Serious
Reportable
Events
Serious Reportable Events In
Healthcare—2011 Update:
A CONSENSUS REPORT
National Quality Forum
The National Quality Forum (NQF) operates under a three-part mission to improve the
quality of American healthcare by:
•building consensus on national priorities and goals for performance improvement
and working in partnership to achieve them;
•endorsing national consensus standards for measuring and publicly reporting on
performance; and
•promoting the attainment of national goals through education and outreach programs.
This project was funded under Department of Health and Human Services.
Recommended Citation: National Quality Forum (NQF), Serious Reportable Events In Healthcare—2011 Update: A Consensus Report, Washington, DC: NQF; 2011.
© 2011. National Quality Forum
All rights reserved
ISBN 978-0-9828421-8-8
No part of this report may be reproduced, stored in a retrieval system, or transmitted, in
any form or by any means electronic, mechanical, photocopying, recording, or otherwise,
without prior permission of the National Quality Forum. Requests for permission to reprint
or make copies should be directed to:
Permissions
National Quality Forum
1030 15th Street NW
Suite 800
Washington, DC 20005
Fax 202-783-3434
www.qualityforum.org
Serious Reportable Events In Healthcare—2011
Update: A Consensus Report
Table of Contents
Executive Summary................................................................................................... ii
Background............................................................................................................. 1
Criteria for Including Events on the List..................................................................... 2
Box A—Criteria for Inclusion.................................................................................. 3
Strategic Directions for NQF...................................................................................... 3
National Priorities Partnership.................................................................................... 4
NQF’s Consensus Development Process...................................................................... 4
Evaluating Potential Consensus Standards................................................................ 4
Relationship To Other NQF-Endorsed Consensus Standards........................................... 5
Recommendations for Endorsement............................................................................. 5
Updated and New Candidate Consensus Standards Recommended for Endorsement.... 6
Surgical or Invasive Procedure Events...................................................................... 6
Product or Device Events........................................................................................ 7
Patient Protection Events........................................................................................ 8
Care Management Events...................................................................................... 9
Environmental Events........................................................................................... 10
Radiologic Events............................................................................................... 11
Potential Criminal Events...................................................................................... 11
Consensus Standards Recommended for Retirement................................................ 12
Candidate Consensus Standards Not Recommended for Endorsement....................... 13
Additional Recommendations................................................................................... 14
Notes................................................................................................................... 15
Appendix A.......................................................................................................... A-1
Appendix B...........................................................................................................B-1
Appendix C.......................................................................................................... C-1
i
National Quality Forum
Serious Reportable Events In Healthcare—2011
Update: A Consensus Report
Executive Summary
THE NATIONAL QUALITY FORUM (NQF)-endorsed® Serious Reportable Events in
Healthcare were released initially in 2002. The purpose of the Serious Reportable Events
(SREs) is to facilitate uniform and comparable public reporting to enable systematic learning across healthcare organizations and systems and to drive systematic national improvements in patient safety based on what is learned both about the events and about how to
prevent their recurrence. Originally envisioned as a set of events that might form the basis
for a national state-based reporting system, the SREs continue to fill that purpose as organizations, independent of NQF, have put them into practice. Additionally, they have been
used or adapted by national entities with the goal of illuminating such events to facilitate
learning and improvement.
The purpose of the 2011 update is to: 1) ensure the continued currency and appropriateness of each event in the list; 2) ensure the events remain appropriate for public accountability in light of their standing as voluntary consensus standards; and 3) provide guidance
gained by implementers to those just beginning the reporting of these events, across hospitals and for three newly specified settings of care—office-based practices, ambulatory
surgery centers, and skilled nursing facilities.
This second update of NQF’s Serious Reportable Events presents the results of evaluating the 28 NQF-endorsed SREs, with recommended modifications, and 12 new events
considered under NQF’s Consensus Development Process (CDP). After evaluation against
the threshold criteria of unambiguous, largely, if not entirely, preventable, and serious, 29
events are recommended for endorsement as voluntary consensus standards suitable for
public reporting.
ii
National Quality Forum
Serious Reportable Events In Healthcare—2011 Update
Serious Reportable Events in Healthcare—2011 Update
1. Surgical or Invasive Procedure Events
A. Surgery or other invasive procedure performed on the wrong site
B. Surgery or other invasive procedure performed on the wrong patient
C. Wrong surgical or other invasive procedure performed on a patient
D. Unintended retention of a foreign object in a patient after surgery or other invasive procedure
E. Intraoperative or immediately postoperative/postprocedure death in an ASA Class 1 patient
2. Product or Device Events
A. Patient death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by the healthcare setting
B. Patient death or serious injury associated with the use or function of a device in patient care, in
which the device is used or functions other than as intended
C. Patient death or serious injury associated with intravascular air embolism that occurs while being cared for in a healthcare setting
3. Patient Protection Events
A. Discharge or release of a patient/resident of any age, who is unable to make decisions, to
other than an authorized person
B. Patient death or serious injury associated with patient elopement (disappearance)
C. Patient suicide, attempted suicide, or self-harm that results in serious injury, while being cared
for in a healthcare setting
4. Care Management Events
A. Patient death or serious injury associated with a medication error (e.g., errors involving the
wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or
wrong route of administration)
B. Patient death or serious injury associated with unsafe administration of blood products
C. Maternal death or serious injury associated with labor or delivery in a low-risk pregnancy
while being cared for in a healthcare setting
iii
National Quality Forum
National Quality Forum
4. Care Management Events (cont.)
D. Death or serious injury of a neonate associated with labor or delivery in a low-risk pregnancy
E. Patient death or serious injury associated with a fall while being cared for in a
healthcare setting
F. Any Stage 3, Stage 4, and unstageable pressure ulcers acquired after admission/presentation
to a healthcare setting
G. Artificial insemination with the wrong donor sperm or wrong egg
H. Patient death or serious injury resulting from the irretrievable loss of an irreplaceable biological
specimen
I. Patient death or serious injury resulting from failure to follow up or communicate laboratory,
pathology, or radiology test results
5. Environmental Events
A. Patient or staff death or serious injury associated with an electric shock in the course of a patient care process in a healthcare setting
B. Any incident in which systems designated for oxygen or other gas to be delivered to a patient
contains no gas, the wrong gas, or are contaminated by toxic substances
C. Patient or staff death or serious injury associated with a burn incurred from any source in the
course of a patient care process in a healthcare setting
D. Patient death or serious injury associated with the use of physical restraints or bedrails while
being cared for in a healthcare setting
6. Radiologic Events
A. Death or serious injury of a patient or staff associated with the introduction of a metallic object
into the MRI area
7. Potential Criminal Events
A. Any instance of care ordered by or provided by someone impersonating a physician, nurse,
pharmacist, or other licensed healthcare provider
B. Abduction of a patient/resident of any age
C. Sexual abuse/assault on a patient or staff member within or on the grounds of a
healthcare setting
D. Death or serious injury of a patient or staff member resulting from a physical assault
(i.e., battery) that occurs within or on the grounds of a healthcare setting
iv
National Quality Forum
Serious Reportable Events In Healthcare—2011
Update: A Consensus Report
Background
THE NQF-ENDORSED® SERIOUS REPORTABLE EVENTS in Healthcare were released
initially in 2002, one of the first products of the ongoing effort to enable healthcare quality
and safety improvement through introduction of tools for assessing, measuring, and reporting organizational performance. Those efforts were aimed, as they are now, at facilitating
learning within the healthcare industry that would lead to delivery of high-quality and safer
healthcare. Then, as now, the focus is on what can be done on the part of all members of
the healthcare enterprise to ensure that those who seek care are protected from injury while
receiving “world-class” healthcare. This can occur only when all parts of the healthcare
industry work together to find and correct unsafe conditions in the spirit of providing an
environment that is safe for patients and for those involved in the delivery of care. Each
individual event (rather than frequencies of events) should be reported and investigated by
healthcare institutions as they occur.
The purpose of the NQF-endorsed list of Serious Reportable Events in Healthcare is to
facilitate uniform and comparable public reporting to enable systematic learning across
healthcare organizations and systems and to drive systematic national improvements in
patient safety based on what is learned—both about the events and about how to prevent
their recurrence. The serious reportable events (SREs) were originally envisioned as a set
of events that might form the basis for a national state-based reporting system, and they
continue to serve that purpose. Additionally, they have been used or adapted by national
entities with the goal of illuminating such events to facilitate learning and improvement.
Every healthcare organization is, and should want to be, accountable for the quality of
care it delivers and the safety of all it serves—staff, visitors, families, and most particularly,
patients. Accountability in this context encompasses: 1) diligent effort to discover vulnerabilities that could lead to adverse events; 2) focused review and analysis of events that
do occur to determine causal or contributing factors; 3) applying what is learned to continuously improve quality; and 4) public reporting to enable other organizations to apply
lessons learned and take actions to prevent recurrence. All who report such events or sponsor reports should recognize and respect the fact that using reports to fix blame is counterproductive in the patient safety improvement effort. Additionally, as part of the effort to
understand and reduce events it is important that healthcare providers and professionals
communicate when events occur that cross organizational boundaries. For example, the
1
National Quality Forum
National Quality Forum
admission of a patient into a hospital after
experiencing an event in an outpatient surgicenter should result in communication between
the two institutions to allow understanding and
learning on the part of both organizations.
Further guidance related to publicly reporting patient safety events is available in National Voluntary Consensus Standards for Public
Reporting of Patient Safety Event Information: A
Consensus Report.1
In keeping with the expectations set in the
initial report, Serious Reportable Events in
Healthcare—2011 Update has undergone
significant changes. The purpose of the update
is to: 1) ensure the continued currency and
appropriateness of each event in the list; 2)
ensure the events remain appropriate for public
accountability in light of their standing as
voluntary consensus standards; and 3) provide
guidance gained by implementers to those just
beginning to report these events across hospitals. Additionally, effort has been made to
clarify what events should be reported for three
other settings of care: office-based practices,
ambulatory surgery centers, and skilled nursing
facilities. In large part the differences across
the four settings are nuances that find their way
into the implementation guidance rather than
necessitate significantly different specifications.
It should be noted that a focus on these four
settings of care does not preclude use of the
events in other settings of care.
In all events where “serious disability” was
part of the event description, the term has been
replaced by “serious injury” to broaden application of the event. In some events, this has
been further broadened to capture change in
2
patient risk status when the risk change requires long-term care or monitoring.
State, legal, or other jurisdictional boundaries that take precedence in the way the
events are interpreted should be respected in
reporting the events. The Steering Committee
(Committee) was mindful of the jurisdictional
boundaries as well as the importance of comparability within settings of care over time. For
these reasons, changes to existing events were
made only to the extent warranted by experience gained in their use and current evidence.
Criteria for Including Events on the List
To qualify for the list of SREs, an event must be
unambiguous, largely preventable, and serious,
as well as adverse, indicative of a problem in
a healthcare setting’s safety systems, or important for public credibility or public accountability. Some SREs are universally preventable
and should never occur. Others are largely
preventable and may be reduced to zero as
knowledge and improved prevention strategies
evolve. SREs that are entirely preventable and
those that are largely preventable should be
publicly reported. The criteria for inclusion (see
Box A) and the definitions of terms (see Appendix B, Glossary) were closely reviewed, debated, revised, and subjected to public comment
before being finalized for use in this update.
The events described in this report meet those
criteria; however, they do not represent all
adverse events that might be useful to report or
from which the healthcare industry can learn
and make improvements. Further, presence of
an event on the list is not an a priori judgment
either of a systems failure or a lack of due
care.
National Quality Forum
Serious Reportable Events In Healthcare—2011 Update
Box A—Criteria for Inclusion
To qualify for the list of Serious Reportable Events in Healthcare—2011 Update an event must
be unambiguous, largely, if not entirely, preventable, serious, and any of the following:
adverse
indicative of a problem in a healthcare setting’s safety systems
important for public credibility or public accountability
Additionally, items included on the list are events that are:
of concern to both the public and healthcare professionals and providers;
clearly identifiable and measurable; and
thus feasible to include in a reporting system; and
of a nature such that the risk of occurrence is significantly influenced by the policies
and procedures of the healthcare facility.
The majority of events on the list are events
that, over the years since they were endorsed
as voluntary consensus standards, have continued to meet the criteria by which they were
selected and have been accepted by organizations and states as appropriate for reporting
but yet have continued to occur.
STRATEGIC DIRECTIONS
FOR NQF
NQF’s mission includes three parts: 1) building consensus on national priorities and goals
for performance improvement and working in
partnership to achieve them, 2) endorsing national consensus standards for measuring and
publicly reporting on performance, and
3) promoting the attainment of national goals
through education and outreach programs. As
3
greater numbers of quality (including safety)
measures are developed and brought to NQF
for consideration of endorsement, it is incumbent on NQF to assist stakeholders to “measure
what makes a difference” and address what
is important to achieve the best outcomes for
patients and populations.
Several strategic issues have been identified
to guide consideration of candidate consensus
standards:
DRIVE TOWARD HIGH PERFORMANCE. Over time,
the bar of performance expectations should be
raised to encourage the achievement of higher
levels of system performance.
EMPHASIZE COMPOSITES. Composite measures
provide much-needed summary information
pertaining to multiple dimensions of performance and are more comprehensible to
patients and consumers.
National Quality Forum
National Quality Forum
MOVE TOWARD OUTCOME MEASUREMENT. Outcome
measures provide information of keen interest
to consumers and purchasers, and when
coupled with healthcare process measures,
they provide useful and actionable information
to providers. Outcome measures also focus
attention on much-needed system-level improvements, because achieving the best patient
outcomes often requires carefully designed
care processes, teamwork, and coordinated
action on the part of many providers.
National Priorities
Partnership
CONSIDER DISPARITIES IN ALL WE DO. Some of the
greatest performance gaps relate to care of
minority populations. Particular attention should
be focused on identifying disparities-sensitive
performance measures and on identifying
the most relevant race/ethnicity/language/
socioeconomic strata for reporting purposes.
patient and family engagement,
population health,
safety,
care coordination,
palliative and end-of-life care,
overuse,
equitable access, and
infrastructure support.
These strategic directions were considered
as the 2011 list of serious reportable events
was under development. Since its inception,
NQF has focused on driving toward high
performance through improving safety across
the healthcare enterprise. Serious Reportable
Events in Healthcare, published in 2002, was
one of the first NQF publications. It was updated in 2006 and now has been further updated
and refined to attend to specific issues in four
designated healthcare settings. In doing so,
special needs of the very young, the elderly,
and those with compromised decision-making
capacity have been considered.
NQF seeks to endorse measures that address
the National Priorities and Goals of the NQFconvened National Priorities Partnership (NPP).2
NPP represents those who receive, pay for,
provide, and evaluate healthcare.
The National Priorities and Goals focus on
these areas:
NQF’s Consensus
Development Process
NQF’s National Voluntary Consensus Standards for Serious Reportable Events in Healthcare—2011 Update project3 seeks to endorse
29 serious adverse events for use by healthcare
institutions, states, and other entities for public
reporting.
Evaluating Potential
Consensus Standards
This report presents the evaluation of an initial
group of 28 endorsed and 12 proposed new
serious reportable events. Candidate consensus
standards and modifications to NQF-endorsed
4
National Quality Forum
Serious Reportable Events In Healthcare—2011 Update
SREs were solicited through a Call for Serious
Reportable Events on May 18, 2010.
The events were evaluated using NQF’s
standard evaluation criteria for serious reportable events, which were refined during this
project (see Box A). Three Technical Advisory
Panels (TAPs) (see Appendix C) evaluated the
endorsed SREs and the proposed modifications
thereto as well as the proposed new SREs to
identify the strengths, weaknesses, and applicability to their respective settings of care to assist the Committee in making recommendations.
The 20-member, multi-stakeholder Committee
provided final evaluations of the events in terms
of the three main criteria: unambiguous, largely
preventable, and serious, as well as the recommendation for endorsement.
Relationship To
Other NQF-Endorsed
Consensus Standards
The 29 endorsed SREs in this report will
become part of a group of NQF-endorsed
consensus standards that specifically address
healthcare safety and therefore address the
National Priorities Partnership focus on safety.
Together with the consensus standards in Safe
Practices for Better Healthcare—2010 Update,4
National Voluntary Consensus Standards for
Public Reporting of Patient Safety Event Information,5 and the rising number of measures related to patient safety that have been endorsed
by NQF, the SREs comprise a group of consensus standards aimed at improving patient
5
safety. This group of safety standards provides
a strong array of nationally accepted tools for
measuring, improving, and reporting safety-related healthcare events that enable and facilitate improvements in healthcare safety.
Although the SREs have been evaluated
and defined in the context of four specific
healthcare settings, they can be applied across
multiple settings, professional disciplines, and
healthcare conditions.
RECOMMENDATIONS
FOR ENDORSEMENT
This report presents the results of the evaluation of 28 endorsed and 12 proposed new
serious reportable events considered under
NQF’s CDP. (For more detailed specifications
and implementation guidance, see Appendix
A.) Twenty-nine SREs have been endorsed
as voluntary consensus standards suitable for
public reporting.
The events are organized in seven categories—six that relate to the provision of care
(surgical or invasive procedure, product or
device, patient protection, care management,
environmental, and radiologic) and one that
includes four potential criminal events. These
latter events include both illegal acts and acts
of unintentional misconduct, and they are
included because they could be indicative
of an environment that is unsafe for patients.
Although a healthcare institution cannot eliminate all risk of these types of events, it can take
preventive measures to reduce that risk.
National Quality Forum
National Quality Forum
The specifications expand and offer clarification of the event to support reporting efforts,
while the implementation guidance provides
context and otherwise facilitates understanding
of the events.
Consistent with the 2002 and 2006 lists
of NQF-endorsed serious reportable events,
this 2011 list is a relatively small and carefully
constructed list of events defined to facilitate
understanding and wide utilization. To facilitate clear understanding, a number of terms
used in this report have been defined for its
use (See Appendix B).
It is particularly important to note that many
of the changes and additions to the SREs,
including definitions, have the potential to
result in an increased number of reports. Public
reports of events, individually or in aggregate,
that are based on event reporting generated
using these updated SREs should acknowledge
this potential both on behalf of the institutions
and for the benefit of consumers who are using
the information to inform their decision-making.
Updated and New Candidate
Consensus Standards Recommended
for Endorsement
Each of these events is intended to be used
for public reporting by healthcare institutions,
states, and other entities as part of healthcare
enterprise-wide efforts to identify, learn from,
and form solutions to such events. All are largely, if not entirely, preventable, and yet all continue to occur. All are potentially indicative of
a problem in the healthcare institutions’ safety
systems and are of a nature such that the risk
6
of occurrence is significantly influenced by the
policies and procedures of the healthcare organization. They are of concern to the public and
healthcare professionals and providers, and
they are important for public credibility and
public accountability. When used as a set for
reporting, the events provide a multidimensional view of the safety of a healthcare organization that cannot be achieved with single eventtype reporting. These characteristics make
each event important for public reporting.
Of the 29 events endorsed, 25 are endorsed
events that have been updated. Based on the
changes to these events, including the specified
care settings, all were subjected to the CDP.
The four new events are identified.
Surgical or Invasive Procedure Events
Each of the surgical or invasive procedure
events was originally specified as a surgery
event, and each was endorsed as part of the
initial set of SREs in 2002. During the past
eight years, these events have continued to
occur without appreciable improvement. The
occurrence of the first four events requires additional, otherwise unnecessary, intervention and
has the potential to cause long-term adverse
consequences for the patient. The Committee agreed that the first four events should be
expanded to include a broader universe of
invasive procedures, many of which occur outside the traditional operating room. Inclusion of
invasive procedures in these four events makes
the determination of when surgery or a procedure ends challenging, thus the definition has
been updated. There was some concern that
including invasive procedures with surgery in
these events could reduce setting-specific learning unless settings are identified in reports.
National Quality Forum
Serious Reportable Events In Healthcare—2011 Update
With respect to the first three events, it was
agreed that although the traditional consent
form might not be used for procedures outside
an operating suite, documentation of informed
consent is essential. The definition of informed
consent and a caveat in the implementation
guidance of each of the three clarifies the
intent.
be explicit about the settings to which the
event as specified applies and to reconsider modifying the event specifications at
a future update.
Product or Device Events
D. Unintended retention of a foreign object
in a patient after surgery or other invasive procedure. The definition of “end of
surgery” has been modified to ensure that
it does not create a circumstance in which
carrying out standard procedures for discovery of a foreign object would create a
reporting requirement.
A. Patient death or serious injury associated
with the use of contaminated drugs, devices, or biologics provided by the healthcare setting. Initially endorsed in 2002,
this event has been modified to clarify the
issue of detectability. Often contaminants
are not visible to the naked eye but can
be detected through monitoring. There has
been a dramatic increase in the spread of
pathogens such as hepatitis and HIV due
to the reuse or improper repurposing of
medical equipment (e.g., endoscopy tubes,
syringes) as well as misuse of medication
vials, injection devices, and containers
(e.g., single-use vials used for more than
one patient, inappropriate access of multidose vials, and pooling of medications).
When such uses become known, it is
essential that organizations investigate and
that appropriate patient monitoring, which
follows national guidelines or standards for
care, occur. The serious injury that occurs
in such cases could be development of disease or the threat of disease that changes
the patient’s risk status for life, requiring
monitoring not needed before the event.
E. Intraoperative or immediately postoperative/postprocedure death in an ASA Class
1 patient. The Committee discussed the
possibility of broadening this event or
creating a new event to capture any death
during or within some specified period after a procedure. The decision was made to
B. Patient death or serious injury associated
with the use or function of a device in
patient care, in which the device is used
or functions other than as intended. As
in the previous event, failure to properly
clean and maintain a device or misuse of
a device that exposes a patient to disease
A. Surgery or other invasive procedure
performed on the wrong site. To be more
inclusive of the range of occurrences that
this event should capture, “body part” was
changed to “site”.
B. Surgery or other invasive procedure
performed on the wrong patient. Because
patients undergoing procedures in outpatient settings typically will not be identified
using wristbands, the implementation guidance for this event includes a caveat about
identification procedures.
C. Wrong surgical or other invasive procedure performed on a patient.
7
National Quality Forum
National Quality Forum
or injury imposes a “serious injury” when
it changes his or her risk status for life,
requiring previously unneeded monitoring
or treatment.
C. Patient death or serious injury associated
with intravascular air embolism that occurs
while being cared for in a healthcare setting. Discussion of this endorsed event centered on concern that the exclusions allow
the occurrence of neurosurgical procedures
identified only as presenting a high risk of
intravascular air embolism to remain unreported. The American Academy of Neurologic Surgeons provided information that
in those cases where surgery is performed
in a position that puts the head above the
heart to reduce venous pressure, development of air embolism is a known risk that is
not entirely preventable. Pediatric experts,
while agreeing that air embolism is not
entirely preventable in some neurosurgical
procedures, expressed differing points of
view about reporting. To be consistent, the
exclusion is retained for both adults and
children at this time.
Patient Protection Events
A. Discharge or release of a patient/resident
of any age, who is unable to make decisions, to other than an authorized person.
This event had been limited to infants. The
Committee determined that it should be
expanded to apply to any individual of
any age who lacks decision-making capacity. The two areas of concern discussed by
the Committee related to the challenges
associated with applying the event in an
outpatient setting and the meaning of the
term “authorized.” The former has been
8
addressed through the implementation
guidance and the latter through definition
and explanatory language in the implementation guidance. Additionally, a definition of decision-making capacity has been
added to the glossary.
B. Patient death or serious injury associated
with patient elopement (disappearance).
Although the issue of accepting an individual into care who subsequently goes missing is important, the struggle with this event
focused on what elopement or disappearance means. The determination was made
that the term “elopement” as defined in the
glossary and the exclusion of competent
(with decision-making capacity) adults who
leave against medical advice or voluntarily
leave without being seen addresses the
concern. It was also noted that some states
and other jurisdictions have defined elopement and, where applicable, those definitions are to be respected.
C. Patient suicide, attempted suicide, or selfharm that results in serious injury, while being cared for in a healthcare setting. The
determination was made that this remains
an important event to be reported. While
the threshold of serious injury associated
with a suicide attempt was initially deleted, concerns about creating a reporting
requirement for specious events led to its
reinsertion. The responsibility for ensuring
safety once an individual is accepted into
care remains in any case. The struggle lies
in the determination of when the individual
has been accepted into care because it
is not reasonable to impose a duty on an
institution for an individual who is on the
National Quality Forum
Serious Reportable Events In Healthcare—2011 Update
premises of the institution but has not yet
presented him- or herself for care (e.g.,
attempts suicide in a restroom prior to
checking in for care). This was addressed
through modification of the additional
specifications.
Care Management Events
A. Patient death or serious injury associated
with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong
patient, wrong time, wrong rate, wrong
preparation, or wrong route of administration). The high rate of medication errors
resulting in injury and death makes this
event important to endorse again. With
this update, two significant additions to the
additional specifications have been made.
One is the administration of a medication
for which there is serious contraindication.
The other relates to failure to observe safe
injection practices (i.e., the improper use
of single dose/single use and multi-dose
containers leading to injury or death as a
result of dosages). Because this update of
the SREs focuses on hospitals, office-based
practices, ambulatory surgery centers,
and skilled nursing facilities, a significant
number of serious and fatal events resulting from community pharmacy dispensing
errors are not captured. When such events
occur during dispensing of medications ordered from the identified sites of care, they
should be included in analyses of causes,
as appropriate.
B. Patient death or serious injury associated
with unsafe administration of blood products. The Committee was of the opinion
that this event should be entirely prevent9
able in any setting. Changes made to
this event included broadening it beyond
hemolytic reaction and changing “serious
disability” to “serious injury.” There was
concern about operationalizing “unsafe.”
Implementation guidance has been added
to address this concern.
C. Maternal death or serious injury associated with labor or delivery in a low-risk
pregnancy while being cared for in a
healthcare setting. The single change to
this event was the change from “serious
disability” to “serious injury” made to all
other events with this language. Although
there was discussion of removing the exclusions, doing so is not recommended at this
time. It will be revisited when the list is next
reviewed.
D. Death or serious injury of a neonate associated with labor or delivery in a lowrisk pregnancy. (NEW) This new event is
a companion to, and equally important
as, death or serious injury of the mother in
similar circumstances. To capture the fuller
range of potential birthing locations, the
home setting has been included in the additional specifications.
E. Patient death or serious injury associated with a fall while being cared for
in a healthcare setting. This event was
endorsed in 2002. Initial changes sought
to include physical boundaries where
institution staff have a continuing relationship with the patient. These changes were
seen as especially significant in identifying
the current gaps that offer opportunity for
improvement, such as in the case of a postoperative patient who may have remaining
National Quality Forum
National Quality Forum
influence of medications and who is moving from the interior of a healthcare setting
to a vehicle. At the same time, it was
important there be no responsibility for an
individual prior to acceptance as a patient.
With additional input and discussion, the
2006 language was retained. The Committee decided to move this event from the
Environmental Events group to the Care
Management Events group at this time.
The question of moves of other events as
well as the typology used for grouping
events will be further considered in future
updates to the SREs.
F. Any Stage 3, Stage 4, and unstageable
pressure ulcers acquired after admission/presentation to a healthcare setting.
Updates to this event include the addition
of “unstageable” based on harmonization
with the National Pressure Ulcer Advisory
Panel’s (NPUAP) position and definitions.
Although possible inclusion of deep tissue
injury was discussed, determination was
made that this would amount to reporting
an unconfirmed suspicion. Also, there
was discussion of preventability and,
while acknowledging that some pressure
ulcers cannot be prevented, determination
was made that pressure ulcers as defined
by this event and the NPUAP should be
reported.
G. Artificial insemination with the wrong
donor sperm or wrong egg. This event,
first endorsed in 2006, is continued
unchanged other than to specify three settings of care to which it applies.
H. Patient death or serious injury resulting
from the irretrievable loss of an irreplace10
able biological specimen. (NEW) The
Committee readily agreed on the importance of this newly submitted event. Discussion of this event centered on the meaning of “irretrievable,” which was addressed
both in the specifications and implementation guidance. As with the event related
to use of contaminated drugs, etc., serious
injury could be the progress of an undiagnosed disease or the threat of disease that
changes the patient’s risk status for life,
requiring monitoring not needed before the
event.
I. Patient death or serious injury resulting
from failure to follow up or communicate
laboratory, pathology, or radiology test results. (NEW) The Committee agreed on the
importance of this newly submitted event
and acknowledged that the issue of failure
to follow up or communicate imposes significant increased risk of death or serious
injury (e.g., change in stage of cancer).
With continued discussion, the event was
modified to limit its scope to those areas
from which critical information in the form
of test results most often come, with an
expectation that it could be expanded in
future updates.
Environmental Events
A. Patient or staff death or serious injury associated with an electric shock in the course
of a patient care process in a healthcare
setting. This event, which was endorsed in
2002, has been expanded to include staff
death or serious injury. Explanation of the
intent of the addition has been added to
the implementation guidance.
National Quality Forum
Serious Reportable Events In Healthcare—2011 Update
B. Any incident in which systems designated
for oxygen or other gas to be delivered to
a patient contain no gas, the wrong gas,
or are contaminated by toxic substances.
This event, which was endorsed in 2002,
has been refined to ensure that events
involving both remote and bedside systems
are included and that cases in which gas
is not delivered when it has been prescribed are captured.
C. Patient or staff death or serious injury
associated with a burn incurred from any
source in the course of a patient care process in a healthcare setting. This event was
endorsed in 2002. It has been expanded
to include staff death or serious injury.
Implementation guidance has been added
to provide examples of the array of burns
that are possible.
D. Patient death or serious injury associated
with the use of physical restraints or bedrails while being cared for in a healthcare
setting. The single change to this event,
initially endorsed in 2002, was the addition of “physical.” The Committee acknowledged concern about the issue of chemical
restraints but determined that difficulty in
defining such events makes their inclusion
infeasible at present.
Radiologic Events
A. Death or serious injury of a patient or
staff associated with the introduction of a
metallic object into the MRI area. (NEW)
This event is an adaptation of a newly
proposed event. The occurrence of such
events continues to be recognized, suggesting that there is an opportunity for discov-
11
ery and learning to reduce the occurrence.
After discussion and consultation with experts in MRI processes and environments,
the event was clarified and expanded
to include death or serious injury of staff
as well as patients. Because radiologic
events of various types are occurring with
increasing frequency, this event is included
in a new category, “Radiologic Events,”
in anticipation that additional events will
be added to this category in future SRE
updates.
Potential Criminal Events
The category title has been changed by the
addition of “potential,” recognizing that at the
time of occurrence, there may be no determination of intent. In fact, the occurrence may
be determined to be unintentional very early
on (e.g., the patient with dementia who harms
another). Although the latter event results in unintentional harm, it can indicate a problem with
the safety systems in the healthcare setting.
The overarching discussion about this group of
events was related to redundant reporting and
the potential for compromising the event-related
information. Committee members experienced
in medical event-related judicial proceedings
noted that the legal pathway has no interest in
learning, improvement, or prevention; thus the
events are appropriately included in the SREs
for those reasons. Further, these events are
rare; and although there is a certain amount of
redundancy in data collection or reporting, the
burden should be relatively light. Of note, use
of the term “patient” in these events is intended
to convey that the individual has presented for
care, is under care, or has received care and
has not yet left the healthcare setting grounds.
National Quality Forum
National Quality Forum
A. Any instance of care ordered by or provided by someone impersonating a physician,
nurse, pharmacist, or other licensed healthcare provider. No changes were made to
the specifications of this event, which was
initially endorsed in 2002. Implementation guidance was added to provide some
clarification regarding what it is intended
to capture.
B. Abduction of a patient/resident of any
age. This event, endorsed in 2002, was
changed to include “resident” in keeping
with the nomenclature used in long-term
care settings. Implementation guidance
was added to clarify what it is intended to
be captured.
C. Sexual abuse/assault on a patient or staff
member within or on the grounds of a
healthcare setting. This event, endorsed
in 2002, was changed to add staff to the
reporting requirement.
D. Death or serious injury of a patient or staff
member resulting from a physical assault
(i.e., battery) that occurs within or on
the grounds of a healthcare setting. The
change made to this event, endorsed in
2002, is limited to changing “significant”
to “serious” and “facility” to “setting,” for
consistency across the events.
Consensus Standards Recommended
for Retirement
Three Care Management events are recommended for retirement. The Committee recommends that when an event represents an
example of a type of event, it be reported
12
under the rubric of the event type or category
rather than creating a proliferation of single
events representative of the type or category.
Two events recommended for retirement are
examples.
Formerly Care Management Event 4.D.
Patient death or serious disability associated with hypoglycemia, the onset
of which occurs while the patient is being cared for in a healthcare facility
Onset of hypoglycemia in a healthcare
setting is an example of a medication management event, and as such, the Committee recommends that events related to insulin dosing be
included as an explicit example of occurrences
to be reported under the Care Management
event related to death or serious injury associated with a medication error (4.A.). Further, the
“Additional Specifications” of that event have
been changed to include over- or under-dosing.
Formerly Care Management Event 4.E.
Death or serious disability (kernicterus)
associated with failure to identify and
treat hyperbilirubinemia in neonates
Development of kernicterus is an example
of failure to follow up or communicate clinical
information, a new care management event
proposed for this 2011 update. The committee,
therefore, recommends that the event be retired
and that its intent be added to the “Additional
Specifications” of the new event. This recognizes the importance of continued diligence in the
effort to detect signs of hyperbilirubinemia and
the potential for kernicterus, while providing a
category for capturing a wider range of events
related to failure to follow up on important clinical information.
National Quality Forum
Serious Reportable Events In Healthcare—2011 Update
Formerly Care Management Event 4.G.
Patient death or serious disability due
to spinal manipulative therapy
The Committee identified this event as one
that targets a specific group of healthcare providers. Further, the event is related to individual
provider behavior rather than facility safety systems. Based on these facts, it is recommended
that this event be retired.
Candidate Consensus Standards Not
Recommended for Endorsement
Of the eight proposed new SREs that are not
recommended for endorsement, elements of
three have been incorporated into the implementation guidance of other SREs for which
endorsement is recommended. Additionally,
some of the eight events not recommended in
this update can be expected to be included in
future updates as experience and the evidence
evolves.
Patient death or serious injury associated with
prolonged fluoroscopy with cumulative dose
>1500 rads to a single field or any delivery of
radiotherapy to the wrong body region or 25
percent above or below the planned radiotherapy dose
The complexity of this proposed event
coupled with the input from experts in fluoroscopy and radiotherapy resulted in the Committee recommending against advancing this event
at this time. At present, fluoroscopy equipment
does not provide dose maps after a procedure,
and the measurement systems used for dosages
are changing. Further, dosages differ based on
a number of factors, including body location.
13
These factors would require extensive, detailed
specifications that would depend on the ability
to articulate a number of variables clearly,
some of which are transitioning to new methods. The Committee recommends this event be
held for consideration at the next update.
Patient death or serious injury related to a
central line associated blood stream infection
(CLABSI)
The development of blood stream infections
associated with clinical care is an important
occurrence that can be related to failure of
organizational policy and procedures or the
enforcement and surveillance of these policies
and procedures. The Committee opined that
development of such an infection (versus death
or serious injury) should be reported; however,
the event is not recommended for endorsement
at this time because of issues related to attributing causality as well as relative lack of measurement experience and reporting. The event
will be revisited in the next SRE update cycle.
Death among surgical patients with serious
treatable complications (failure to rescue)
In the context of an SRE, ascertainment
would be difficult due to the potential breadth
of complications to be defined and linked to
failure to rescue. At this juncture, the event
can best be captured, albeit in the aggregate,
using a performance measure. NQF has
endorsed three such measures, and although
similar, each measure applies to different
populations. At some future date, the feasibility
of linking the SREs with performance measures
should be explored; however, the complexity
of individual event reporting that would result
requires careful consideration.
National Quality Forum
National Quality Forum
Arterial misplacement and use of a central
venous catheter
Diagnostic testing error resulting in unnecessary invasive procedure, serious disability, or
death
Incorrect placement of a feeding (gastrointestinal) or ventilation tube, which results in
patient harm
A guiding principle applied by the Committee in its deliberations of the three foregoing
proposed events was that individual examples
of event types should, where possible, be
captured within SREs that capture the broader
type rather than as individual events. The three
events above are examples of broader categories of events in the proposed list and have
been included as such in the relevant event
implementation guidance.
Death or serious injury resulting from care
provided by an impaired healthcare worker
Death or significant injury of a patient as a
consequence of staff impaired by recreational
drugs or alcohol use
The Committee acknowledged that the issue
at the center of these two foregoing proposed
events is important. However, the issue is complex given the range of substances that could
be involved, including at least one that may be
legalized in some states; the types of impairments that could be involved; the ability to
determine or verify the impairment objectively;
and the point at which impairment could be declared and reported. Due to these challenges,
these events are not recommended at this time.
Additional
Recommendations
Although the list of serious reportable events
has been in use to varying degrees across
states and healthcare organizations, significant
opportunity for improving the list through research remains. The NQF report National Voluntary Consensus Standards for Public Reporting of Patient Safety Event Information6 outlined
a number of recommendations, of which four
are repeated here, either verbatim or modified
to be specific to SREs.
• Research and evaluation should be con-
ducted to determine which events convey
a valid, reliable perspective of healthcare
organization safety.
• Research should be conducted to evaluate
the impact of public reporting of patient
safety information on patients, consumers,
and healthcare institutions.
• Organizations that collect patient safety reports from healthcare providers, those that
design collection systems for such reports,
those that design classification systems for
event reporting, and other stakeholders
should come together and begin to harmonize standardized systems for defining,
measuring, reporting, analyzing, and
classifying patient safety information in a
way that produces greater data integrity,
completeness, and reliability and, therefore, greater understanding of events, and
reduces opportunity costs associated with
these activities.
• Health information technology systems
and any funds that become available to
improve them should include provision for
facilitating patient-safety related data cap-
14
National Quality Forum
Serious Reportable Events In Healthcare—2011 Update
ture in ways that can be used for public
reporting.
Additionally, Serious Reportable Events in
Healthcare 2002 and the 2006 Update included recommendations that remain relevant
and should be addressed. These include:
• exploring effective mechanisms to collect
data and communicate serious reportable
events to the public;
• examining how data derived from using
the NQF list can be disclosed in a way
that meets the public’s needs, yet is balanced with the need for providers to learn
from mistakes;
• testing the operational value and utility of
the events on the list, including research on
the necessity to support such a list and the
public’s perceptions of the impact of the
list;
• identifying ICD, CPT, or other codes that
correlate with each serious reportable
event on the list; and
• identifying effective mechanisms, including
standardization of reporting systems, to
permit institutions to report an event that
occurs in their organization only once to a
single entity from which needed information can be extracted and to avoid double
reporting when a patient receives care in
more than one healthcare organization;
• evaluating comparability of data reported
the degree to which comparability exists
and to define next steps toward improving
comparability;
• evaluating outcomes of public reporting in
terms of both reduction in occurrences of
these events and identification and use of
practices to prevent such occurrences; and
• evaluating population- or geographic-
based differences in rates of occurrence of
these events for purposes of determining reporting and/or occurrence variations and
designing appropriate population-specific
interventions.
NOTES
1. National Quality Forum (NQF), National Voluntary Consensus Standards for Public Reporting of Patient Safety Event
Information: A Consensus Report, NQF: Washington, DC;
2011.
2.NQF, National Priorities Partnership, Washington, DC: NQF.
Available at www.nationalprioritiespartnership.org. Last
accessed October 2010.
3. Available at http://qualityforum.org/projects/hacs_and_
sres.aspx. Last accessed October 2010.
4.NQF, Safe Practices for Better Healthcare—2010 Update: A
Consensus Report, NQF: Washington, DC; 2010.
5.NQF, National Voluntary Consensus Standards for Public
Reporting of Patient Safety Event Information: A Consensus
Report, NQF: Washington, DC; 2011.
6.Ibid.
across healthcare systems to determine
15
National Quality Forum
Serious Reportable Events In Healthcare—2011
Update: A Consensus Report
Appendix A
Specifications of the Serious Reportable Events In
Healthcare—2011 Update
THE FOLLOWING TABLE PRESENTS the specifications for the proposed consensus
standards. The information presented represents an update of the 2006 report with revision and additions made by the Serious Reportable Events Steering Committee utilizing
NQF Member and public submissions and consultation with experts in the various fields.
These proposed voluntary consensus standards are the intellectual property of the National
Quality Forum, and as such they are open source, fully accessible, and disclosed.
Definitions of key terms are included in the Glossary (Appendix B) and, where the terms
are used in the event description or additional specifications, are considered part of the
specifications of the events.
Implementation Guidance is not proposed for endorsement. It amplifies statements in the
Event and Additional Specifications, which are proposed for endorsement, with examples
and explanations based on experience of those organizations/entities that have implemented event reporting as well as recommendations of the NQF Serious Reportable Events
Steering Committee. It does not purport to be either comprehensive or even across the
events and is not a requirement of either.
A-1
National Quality Forum
Appendix A - Specifications of the Serious Reportable
Events In Healthcare—2011 Update
1. SURGICAL OR INVASIVE PROCEDURE EVENTS
Event: 1A. Surgery or other invasive procedure performed on the wrong site
Additional Specifications: Defined as any surgery or other invasive procedure performed on a body part or site that is not consistent
with the correctly documented informed consent for that patient.
Surgery or other invasive procedure includes, but is not limited to, endoscopies, lens implants, lesion removal, injection into joints.
Excludes emergent situations that occur in the course of surgery or other invasive procedure and/or whose exigency precludes obtaining
informed consent.
Implementation Guidance: It should be noted that a correctly documented informed consent for patients whose procedures will not be
carried out in an operating room may not involve a “surgical consent form”; however, it does require informed consent be documented in
the patient record.
Although an incorrectly placed surgical mark could result in surgery being performed on the wrong body part, surgery does not begin
at time the surgical mark is made on the patient. Placing a mark on the wrong body part or site does not in itself constitute wrong site
surgery.
Wrong site surgery or invasive procedure, corrected during the procedure, is still a wrong site procedure if the surgery/procedure had
begun, based on the definition in glossary.
This event is intended to capture instances of:
• surgery or other invasive procedure on the right body part but on the wrong location/site on the body; e.g., left/right
(appendages/organs), wrong digit, level (spine), stent placed in wrong iliac artery, steroid injection into wrong knee, biopsy
of wrong mole, burr hole on wrong side of skull;
• delivery of fluoroscopy or radiotherapy to the wrong region of the body;
• use of incorrectly placed vascular catheters;
• use of incorrectly placed tubes (for example, feeding tubes placed in the lung or ventilation tubes passed into the esophagus).
This event is not intended to capture:
• changes in plan upon entry into the patient with discovery of pathology in close proximity to the intended place where risk
of a second surgery or procedure outweighs benefit of patient consultation, or unusual physical configuration (for example
adhesions, spine level/extra vertebrae).
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
• Long-term Care/Skilled Nursing Facilities
A-2
National Quality Forum
Appendix A - Specifications of the Serious Reportable
Events In Healthcare—2011 Update
1. SURGICAL OR INVASIVE PROCEDURE EVENTS (CONT.)
Event: 1B. Surgery or other invasive procedure performed on the wrong patient
Additional Specifications: Defined as any surgery or invasive procedure on a patient that is not consistent with the correctly
documented informed consent for that patient.
Surgery or other invasive procedure includes, but is not limited to, endoscopies, lens implants, lesion removal, injection into joints.
Implementation Guidance: It should be noted that a correctly documented informed consent for patients whose procedures will
not be carried out in an operating room may not involve a “surgical consent form”; however, it does require informed consent be
documented in the patient record.
This event is intended to capture:
• surgical procedures (whether or not completed) initiated on one patient intended for a different patient.
Use of accepted patient identification procedures is key to avoiding such events.
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/ Office-based Practices
• Long-term Care/Skilled Nursing Facilities
Event: 1C. Wrong surgical or other invasive procedure performed on a patient
Additional Specifications: Defined as any surgical or other invasive procedure performed on a patient that is not consistent with
the correctly documented informed consent for that patient.
Surgery or other invasive procedure includes, but is not limited to, endoscopies, lens implants, lesion removal, injection into joints.
Excludes emergent situations that occur in the course of surgery or other invasive procedures and/or whose exigency precludes
obtaining informed consent..
Implementation Guidance: It should be noted that a correctly documented informed consent for patients whose procedures will
not be carried out in an operating room may not involve a “surgical consent form”; however, it does require informed consent be
documented in the patient record.
This event is intended to capture:
• insertion of the wrong medical implant into the correct surgical site.
This event is not intended to capture: changes in plan upon entry into the patient with discovery of pathology in close proximity
to the intended place where risk of a second surgery/ procedure outweighs benefit of patient consultation, or unusual physical
configuration (for example adhesions, spine level/extra vertebrae)..
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
• Long-term Care/Skilled Nursing Facilities
A-3
National Quality Forum
Appendix A - Specifications of the Serious Reportable
Events In Healthcare—2011 Update
1. SURGICAL OR INVASIVE PROCEDURE EVENTS (CONT.)
Event: 1D. Unintended retention of a foreign object in a patient after surgery or other invasive procedure
Additional Specifications: Includes medical or surgical items intentionally placed by provider(s) that are unintentionally left in place.
Excludes a) objects present prior to surgery or other invasive procedure that are intentionally left in place; b) objects intentionally
implanted as part of a planned intervention; and c) objects not present prior to surgery/procedure that are intentionally left in when the
risk of removal exceeds the risk of retention (such as microneedles, broken screws).
Implementation Guidance: This event is intended to capture:
• occurrences of unintended retention of objects at any point after the surgery/procedure ends regardless of setting (post
anesthesia recovery unit, surgical suite, emergency department, patient bedside) and regardless of whether the object is to be
removed after discovery;
• unintentionally retained objects (including such things as wound packing material, sponges, catheter tips, trocars, guide wires)
in all applicable settings.
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/ Office-based Practices
• Long-term Care/Skilled Nursing Facilities
Event: 1E. Intraoperative or immediately postoperative/postprocedure death in an ASA Class I patient
Additional Specifications: Includes all ASA Class I patient deaths in situations where anesthesia was administered; the planned surgical
procedure may or may not have been carried out.
Immediately post-operative means within 24 hours after surgery or other invasive procedure was completed or after administration of
anesthesia (if surgery/procedure not completed).
Implementation Guidance: This event is intended to capture:
• ASA Class I patient death associated with the administration of anesthesia whether or not the planned surgical procedure was
carried out.
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
A-4
National Quality Forum
Appendix A - Specifications of the Serious Reportable
Events In Healthcare—2011 Update
2. PRODUCT OR DEVICE EVENTS
Event: 2A. Patient death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by
the healthcare setting
Additional Specifications: Includes contaminants in drugs, devices, or biologics regardless of the source of contamination and/or
product.
Includes threat of disease that changes patient’s risk status for life requiring medical monitoring not needed before the event
Implementation Guidance: This event is intended to capture:
• contaminations that can be seen with the naked eye or with use of detection mechanisms in general use. These
contaminations are to be reported at such time as they become known to the provider or healthcare organization.
Contaminants may be physical, chemical, or biological in nature. Not all contaminations can be seen with the naked eye (e.g.,
hepatitis and HIV) or readily detected using generally available or more specialized testing mechanisms (e.g., cultures, nucleic
acid testing, mass spectrometry, and tests that signal changes in pH or glucose levels). Contamination that is inferred and
changes risk status for life (e.g., consider a syringe or needle contaminated once it has been used to administer medication to
a patient by injection or via connection to a patient’s intravenous infusion bag or administration set).
This event is intended to capture:
• administration of contaminated vaccine or medication (e.g., intramuscular antibiotic);
• serious infection from contaminated drug or device used in surgery or an invasive procedure (e.g., a scalpel);
• occurrences related to use of improperly cleaned or maintained device.
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
• Long-term Care/Skilled Nursing Facilities
Event: 2B. Patient death or serious injury associated with the use or function of a device in patient care, in which the device
is used or functions other than as intended
Additional Specifications: Includes, but is not limited to, catheters, drains, and other specialized tubes, infusion pumps, ventilators, and
procedural and monitoring equipment.
Implementation Guidance: This event is intended to capture:
• occurrences whether or not the use is intended or described by the device manufacturers’ literature
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
• Long-term Care/Skilled Nursing Facilities
A-5
National Quality Forum
Appendix A - Specifications of the Serious Reportable
Events In Healthcare—2011 Update
2. PRODUCT OR DEVICE EVENTS (CONT.)
Event: 2C. Patient death or serious injury associated with intravascular air embolism that occurs while being cared for in a
healthcare setting
Additional Specifications: Excludes death or serious injury associated with neurosurgical procedures known to present a high risk of
intravascular air embolism.
Implementation Guidance: This event is intended to capture:
• high-risk procedures, other than neurosurgical procedures, that include, but are not limited to, procedures involving the head
and neck, vaginal delivery and caesarean section, spinal instrumentation procedures, and liver transplantation;
• low-risk procedures, including those related to lines placed for infusion of fluids in vascular space.
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Long-term Care/Skilled Nursing Facilities
A-6
National Quality Forum
Appendix A - Specifications of the Serious Reportable
Events In Healthcare—2011 Update
3. PATIENT PROTECTION EVENTS
Event: 3A. Discharge or release of a patient/resident of any age, who is unable to make decisions, to other than an
authorized person.
Implementation Guidance: The terms ”authorized” and “decision-making capacity” are defined in the glossary. Release to “other than
an authorized person” includes removing the patient/resident without specific notification and approval by staff, even when the person is
otherwise authorized.
Examples of individuals who do not have decision-making capacity include: newborns, minors, adults with Alzheimer’s.
Individual healthcare organizations or other relevant jurisdictional authorities may have specific requirements for assessing decisionmaking capacity
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
• Long-term Care/Skilled Nursing Facilities
Event: 3B. Patient death or serious injury associated with patient elopement (disappearance).
Additional Specifications: Includes events that occur after the individual presents him/herself for care in a healthcare setting.
Excludes events involving competent adults with decision-making capacity who leave against medical advice or voluntarily leave without
being seen.
Implementation Guidance: The term “elopement” and “competent” adult should be interpreted in accordance with prevailing legal
standards in applicable jurisdictions.
Of note, an assessment that identifies patients at “risk” of elopement or a chief complaint and findings of risk accompanied by
organizationally defined measures to be taken when risk is identified could be useful in both prevention and event analysis.
This is not intended to capture:
• death or serious injury that occurs (after the patient is located) due to circumstances unrelated to the elopement.
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
• Long-term Care/Skilled Nursing Facilities
A-7
National Quality Forum
Appendix A - Specifications of the Serious Reportable
Events In Healthcare—2011 Update
3. PATIENT PROTECTION EVENTS (CONT.)
Event: 3C. Patient suicide, attempted suicide, or self-harm that results in serious injury, while being cared for in a
healthcare setting
Additional Specifications: Includes events that result from patient actions after they present themselves for care in a healthcare setting.
Excludes deaths resulting from self-inflicted injuries that were the reason for admission/presentation to the healthcare facility.
Implementation Guidance: This event is not intended to capture patient suicide or attempted suicide when the patient is not physically
present in the “healthcare setting “as defined in the glossary.
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
• Long-term Care/Skilled Nursing Facilities
A-8
National Quality Forum
Appendix A - Specifications of the Serious Reportable
Events In Healthcare—2011 Update
4. CARE MANAGEMENT EVENTS
Event: 4A. Patient death or serious injury associated with a medication error (e.g., errors involving the wrong drug, wrong
dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration)
Additional Specifications: Excludes reasonable differences in clinical judgment on drug selection and dose.
Includes, but is not limited to, death or serious injury associated with: a) over- or under-dosing; b) administration of a medication to which
a patient has a known allergy or serious contraindication, c) drug-drug interactions for which there is known potential for death or serious
injury, and d) improper use of single-dose/single-use and multi-dose medication vials and containers leading to death or serious injury as
a result of dose adjustment problems.
Implementation Guidance: This event is intended to capture:
• the most serious medication errors including occurrences in which a patient receives a medication for which there is a
contraindication, or a patient known to have serious allergies to specific medications/agents, receives those medications/
agents, resulting in serious injury or death. These events may occur as a result of failure to collect information about
contraindications or allergies, failure to review such information available in information systems, failure of the organization to
ensure availability of such information and prominently display such information within information systems, or other system
failures that are determined through investigation to be cause of the adverse event;
• occurrences in which a patient dies or suffers serious injury as a result of failure to administer a prescribed medication;
• occurrences in which a patient is administered an over- or under-dose of a medication including insulin, heparin, and any other
high alert medication including but not limited to medications listed on the Institute for Safe Medication Practices “High Alert
Medication List”;
• occurrences in which a patient dies or suffers serious injury as a result of wrong administration technique.
This event is not intended to capture:
• patient death or serious injury associated with allergies that could not reasonably have been known or discerned in advance of
the event.
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
• Long-term Care/Skilled Nursing Facilities
A-9
National Quality Forum
Appendix A - Specifications of the Serious Reportable
Events In Healthcare—2011 Update
4. CARE MANAGEMENT EVENTS (CONT.)
Event: 4B. Patient death or serious injury associated with unsafe administration of blood products
Implementation Guidance: Unsafe administration includes, but is not limited to, hemolytic reactions and administering: a) blood or
blood products to the wrong patient; b) the wrong type; or c) blood or blood products that have been improperly stored or handled.
This event is not intended to capture:
• patient death or serious injury associated with organ rejection other than those attributable to a hyperacute hemolytic reaction
• patient death or injury when cause is not detectable by ABO/HLA matching.
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
• Long-term Care/Skilled Nursing Facility
Event: 4C. Maternal death or serious injury associated with labor or delivery in a low-risk pregnancy while being cared
for in a healthcare setting
Additional Specifications: Includes events that occur within 42 days post-delivery.
Excludes deaths from pulmonary or amniotic fluid embolism, acute fatty liver of pregnancy, or cardiomyopathy.
Implementation Guidance: This event is not intended to create a new obligation. The organization’s obligation, under this event, is to
report only maternal death or serious injury associated with labor or delivery in a low risk pregnancy when made aware of the maternal
death or serious injury either by readmittance or by the patient’s family.
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
Event: 4D. Death or serious injury of a neonate associated with labor or delivery in a low-risk pregnancy
Additional Specifications: Includes, for the office-based surgery, birthing center or “home” setting, unplanned admission to an inpatient
setting within 24 hours of delivery
Implementation Guidance: Unplanned admission to other than the birth setting should be verified with the identified birth setting.
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
A-10
National Quality Forum
Appendix A - Specifications of the Serious Reportable
Events In Healthcare—2011 Update
4. CARE MANAGEMENT EVENTS (CONT.)
Event: 4E. Patient death or serious injury associated with a fall while being cared for in a healthcare setting
Additional Specifications: Includes but is not limited to fractures, head injuries, and intracranial hemorrhage
Implementation Guidance: Of note, an assessment that identifies patients at “risk” of fall, findings of risk accompanied by
organizationally defined measures to be taken when risk is identified could be useful in both prevention and event analysis.
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
• Long-term Care/Skilled Nursing Facilities
Event: 4F. Any Stage 3, Stage 4, and unstageable pressure ulcers acquired after admission/presentation to a healthcare
setting
Additional Specifications: Excludes progression from Stage 2 to Stage 3 if Stage 2 was recognized upon admission and excludes
pressure ulcers that develop in areas where deep tissue injury is documented as present on admission/presentation.
Implementation Guidance: Although this event could occur in the ambulatory surgery environment based on patient condition and
surgery time, it will be difficult to discern. Pre- and post- skin assessment will be key.
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Long-term Care/Skilled Nursing Facilities
Event: 4G. Artificial insemination with the wrong donor sperm or wrong egg
Implementation Guidance: The organization’s obligation is to report the event when made aware of the occurrence.
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
A-11
National Quality Forum
Appendix A - Specifications of the Serious Reportable
Events In Healthcare—2011 Update
4. CARE MANAGEMENT EVENTS (CONT.)
Event: 4H. Patient death or serious injury resulting from the irretrievable loss of an irreplaceable biological specimen.
Additional Specifications: Includes events where specimens are misidentified, where another procedure cannot be done to produce a
specimen
Includes progression of an undiagnosed disease or threat of disease that changes the patient’s risk status for life, requiring monitoring not
needed before the event
Implementation Guidance: This event is not intended to capture:
• procedures where the specimen was properly handled, but the specimen proved to be nondiagnostic.
Inability to secure a replacement for a lost specimen can occur with excisional biopsy as well as in organ removal.
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
• Long-term Care/Skilled Nursing Facilities
Event: 4I. Patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or
radiology test results.
Additional Specifications: Includes events where failure to report increased neonatal bilirubin levels result in kernicterus.
Implementation Guidance: Examples of serious injury are a new diagnosis, or an advancing stage of an existing diagnosis (e.g.,
cancer).
Failure to follow up or communicate can be limited to healthcare staff or can involve communication to the patient.
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
• Long-term Care/Skilled Nursing Facilities
A-12
National Quality Forum
Appendix A - Specifications of the Serious Reportable
Events In Healthcare—2011 Update
5. ENVIRONMENTAL EVENTS
Event: 5A. Patient or staff death or serious injury associated with an electric shock in the course of a patient care process in
a healthcare setting
Additional Specifications: Excludes events involving patients during planned treatments such as electric countershock/elective
cardioversion.
Implementation Guidance: This event is intended to capture:
• patient death or injury associated with unintended electric shock during the course of care or treatment;
• staff death or injury associated with unintended electric shock while carrying out duties directly associated with a patient care
process, including preparing for care delivery.
This event is not intended to capture:
• patient death or injury associated with emergency defibrillation in ventricular fibrillation or with electroconvulsive therapies;
• injury to staff who are not involved in patient care.
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
• Long-term Care/Skilled Nursing Facilities
Event: 5B. Any incident in which systems designated for oxygen or other gas to be delivered to a patient contains no gas,
the wrong gas, or are contaminated by toxic substances
Implementation Guidance: This event is intended to capture:
events in which the line is attached to a reservoir distant from the patient care unit or in a tank near the patient such as
E-cylinders, anesthesia machines.
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
• Long-term Care/Skilled Nursing Facilities
A-13
National Quality Forum
Appendix A - Specifications of the Serious Reportable
Events In Healthcare—2011 Update
5. ENVIRONMENTAL EVENTS (CONT.)
Event: 5C. Patient or staff death or serious injury associated with a burn incurred from any source in the course of a patient
care process in a healthcare setting
Implementation Guidance: This event is intended to capture burns that result from:
• operating room flash fires, including second-degree burn in these cases;
• hot water;
• sunburn in the patient with decreased ability to sense pain;
• smoking in the patient care environment.
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
• Long-term Care/Skilled Nursing Facilities
Event: 5D. Patient death or serious injury associated with the use of physical restraints or bedrails while being cared for in a
healthcare setting
Implementation Guidance: The event is intended to capture:
• instances where physical restraints are implicated in the death, e.g., lead to strangulation/entrapment, etc.
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
• Long-term Care/Skilled Nursing Facilities
A-14
National Quality Forum
Appendix A - Specifications of the Serious Reportable
Events In Healthcare—2011 Update
6. RADIOLOGIC EVENTS
Event: 6A. Death or serious injury of a patient or staff associated with the introduction of a metallic object into the MRI area
Additional Specifications: Includes events related to material inside the patient’s body or projectiles outside the patient’s body.
Implementation Guidance: This event is intended to capture injury or death as a result of projectiles including:
• retained foreign object
• external projectiles
• pacemakers
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
A-15
National Quality Forum
Appendix A - Specifications of the Serious Reportable
Events In Healthcare—2011 Update
7. POTENTIAL CRIMINAL EVENTS
Event: 7A. Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other
licensed healthcare provider
Implementation Guidance: This event is intended to capture:
• those without licensure to provide the care given;
• those with licensure who represent themselves and act beyond the scope of their licensure.
It is not intended to capture individuals who are practicing within the scope of their license on whom patients or others mistakenly bestow
titles beyond that scope when such is not encouraged by the provider
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
• Long-term Care/Skilled Nursing Facilities
Event: 7B. Abduction of a patient/resident of any age
Implementation Guidance: This event is intended to capture:
• removal of a patient/resident, who does not have decisionmaking capacity, without specific notification and approval by staff
even when the person is otherwise authorized to be away from the setting.
Examples of individuals who do not have decisionmaking capacity include: newborns, minors, adults with Alzheimer’s.
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
• Long-term Care/Skilled Nursing Facilities
A-16
National Quality Forum
Appendix A - Specifications of the Serious Reportable
Events In Healthcare—2011 Update
7. POTENTIAL CRIMINAL EVENTS (CONT.)
Event: 7C. Sexual abuse/assault on a patient or staff member within or on the grounds of a healthcare setting
Implementation Guidance: Language and definitions may vary based on state statute; however, the principle and intent remain
regardless of language required based on jurisdiction.
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
• Long-term Care/Skilled Nursing Facilities
Event: 7D. Death or serious injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs
within or on the grounds of a healthcare setting.
Implementation Guidance: Language and definitions may vary based on state statute (e.g., many states have existing statutes that
use the terms “first degree assault” or “second degree assault” or “battery”).
Applicable settings:
• Hospitals
• Outpatient/Office-based Surgery Centers
• Ambulatory Practice Settings/Office-based Practices
• Long-term Care/Skilled Nursing Facilities
A-17
National Quality Forum
Serious Reportable Events In Healthcare—2011
Update: A Consensus Report
Appendix B
Glossary
THE FOLLOWING TERMS ARE DEFINED as they apply to the NQF list of serious
reportable events. To the extent practicable, they have been harmonized with definitions
used in other NQF safety-related products, the Agency for Healthcare Research and
Quality’s Common Formats, and the World Health Organization’s evolving International
Classification for Patient Safety. The Common Formats are a product of the requirements
of the Patient Safety and Quality Improvement Act of 2005 that provides a structure for
reporting adverse events, while the latter provides structure for classifying such events.
B-1
National Quality Forum
Appendix B - Glossary
• Abduction means the taking away of a person by
persuasion, by fraud, or by open force or violence. It
includes convincing someone, particularly a minor or a
woman he/she is better off leaving with the persuader,
telling the person he/she is needed, or that the mother or
father wants him/her to come with the abductor.
• Adverse describes a consequence of care that results in an
undesired outcome. It does not address preventability.
• Associated with means that it is reasonable to initially
assume that the adverse event was due to the referenced
course of care; further investigation and/or root cause
analysis of the unplanned event may be needed to confirm
or refute the presumed relationship.
• Authorized means the guardian or other individual(s)
having the legally recognized ability to consent on behalf
of a minor or incapacitated individual (surrogate), or
person designated by the surrogate to release or consent
for the patient.
• Decision-making capacity is the ability to understand
information relevant to a decision and the ability to
appreciate the reasonably foreseeable consequences of a
decision (or lack of a decision).
• Deep tissue injury presents as a purple or maroon localized
area of discolored intact skin or blood-filled blister due to
damage of underlying soft tissue from pressure and/or
shear. The area may be preceded by tissue that is painful,
firm, mushy, boggy, warmer or cooler as compared to
adjacent tissue.
• Device. See Medical Device.
• Elopement refers to a situation where a patient or resident
who is cognitively, physically, mentally, emotionally,
and/or chemically impaired wanders/walks/runs away,
escapes, or otherwise leaves a caregiving institution or
setting unsupervised, unnoticed, and/or prior to their
scheduled discharge.
• Event means a discrete, auditable, and clearly defined
occurrence.
• Healthcare setting means any facility or office, including a
discrete unit of care within such facility, that is organized,
maintained, and operated for the diagnosis, prevention,
B-2
treatment, rehabilitation, convalescence or other care
of human illness or injury, physical or mental, including
care during and after pregnancy. Healthcare settings
include, but are not limited to, hospitals, nursing homes,
rehabilitation centers, medical centers, office-based
practices, outpatient dialysis centers, reproductive health
centers, independent clinical laboratories, hospices,
ambulatory surgical centers, and pharmacies. The
boundary of a healthcare setting (the “grounds”) is the
physical area immediately adjacent to the setting’s main
buildings. It does not include nonmedical businesses such
as shops and restaurants located close to the setting.
• High alert medications are those medications that have
a high risk of causing serious injury or death to a patient
if they are misused. Examples of high-alert medications
include anticoagulants and IV antithrombotics, insulin,
cytotoxic chemotherapy, concentrated electrolytes, IV
digoxin, opiate narcotics, neuromuscular blocking agents,
and adrenergic agonists. The recommended “High Alert
Medication List” is available at the Institute for Safe
Medication Practices’ website, http://www.ismp.org.
• Infant is a child under the age of one year. (SRE 2006;
Stedman’s online dictionary)
• Informed consent involves a process of shared
decisionmaking in which discussion between a person who
would receive a treatment, including surgery or invasive
procedure, and the caregiver/professional person who
explains the treatment, provides information about possible
benefits, risks and alternatives, and answers questions
that result in the person’s authorization or agreement to
undergo a specific medical intervention. Documentation of
this discussion should result in an accurate and meaningful
entry in the patient record, which could include a signed
“consent form.” Signing a consent form does not
constitute informed consent; it provides a record of the
discussion.
• Injury, as used in this report has a broad meaning. It
includes physical or mental damage that substantially limits
one or more of the major life activities of an individual in
the short term, which may become a disability if extended
long term. Further, injury includes a substantial change
in the patient’s long-term risk status such that care or
National Quality Forum
Appendix B - Glossary
monitoring, based on accepted national standards, is
required that was not required before the event. (Of note,
states and other entities may use alternate definitions for
the term “disability.”)
• Largely preventable recognizes that some of the events
on the SRE list are not universally avoidable, given the
complexity of healthcare and current knowledge.
• Low-risk pregnancy refers to a woman aged 18-39,
with no previous diagnosis of essential hypertension,
renal disease, collagen-vascular disease, liver disease,
cardiovascular disease, placenta previa, multiple gestation,
intrauterine growth retardation, smoking, pregnancyinduced hypertension, premature rupture of membranes, or
other previously documented condition that poses a high
risk of poor pregnancy outcome.
• Medical device is an instrument, apparatus, implement,
machine, contrivance, implant, in vitro reagent, or other
similar or related article, including a component part, or
accessory, which is recognized in the official National
Formulary, or the United States Pharmacopoeia, or any
supplement to them; intended for use in the diagnosis
of disease or other conditions, or in the cure, mitigation,
treatment, or prevention of disease, in man or other
animals; or intended to affect the structure or any
function of the body of man or other animals, and which
does not achieve any of its primary intended purposes
through chemical action within or on the body of man
or other animals and which is not dependent upon being
metabolized for the achievement of any of its primary
intended purposes.1
• Medication error means any preventable event that
may cause or lead to inappropriate medication use or
patient harm while the medication is in the control of
the healthcare professional, patient, or consumer. Such
events may be related to professional practice, healthcare
products, procedures, and systems, including prescribing;
order communication; product labeling, packaging and
nomenclature; compounding; dispensing; distribution;
administration; education; monitoring; and use.2
• Neonate is a newborn less than 28 days of age.
• Patient means a person who is a recipient of healthcare. A
B-3
person becomes a patient at the point that they are being
“cared for” in the facility. Being “cared for” begins when
they are first engaged by a member of the care team, e.g.
assessment by the triage nurse in the E.D., walking with
the phlebotomist to the lab for a lab draw. A patient is
no longer considered a patient at the point that they are
no longer under the care of a member of the care team,
e.g. the nursing assistant has safely assisted the patient to
the car from an inpatient stay; the ambulating patient that
does not need assistance leaves the radiology department
following an outpatient test.3
• Pressure Ulcer, Stage 3 is defined as full thickness tissue
loss. Subcutaneous fat may be visible, but bone, tendon,
or muscle is not exposed. Slough may be present. May
include undermining and tunneling. The depth of a Stage
3 pressure ulcer varies by anatomical location. The bridge
of the nose, ear, occiput, and malleolus do not have
subcutaneous tissue and Stage 3 ulcers can be shallow.
In contrast, areas of significant adiposity can develop
extremely deep Stage 3 pressure ulcers. Bone/tendon is
not visible or directly palpable.4
• Pressure Ulcer, Stage 4 is defined as full thickness tissue
loss with exposed bone, tendon, or muscle. Slough or
eschar may be present. Often includes undermining and
tunneling. The depth of a Stage 4 pressure ulcer varies by
anatomical location. The bridge of the nose, ear, occiput,
and malleolus do not have subcutaneous tissue and these
ulcers can be shallow. Stage 4 ulcers can extend into
muscle and/or supporting structures (e.g., fascia, tendon,
or joint capsule) making osteomyelitis or osteitis likely to
occur. Exposed bone/tendon is visible or directly palpable.5
• Pressure Ulcer, Unstageable is defined as full thickness
tissue loss in which the actual depth of the ulcer is
completely obscured by slough and/or eschar in the
wound bed. Until enough slough and/or exchar are
removed to expose the base of the wound, the true depth
cannot be determined; but it will be either Stage 3 or
Stage 4.6
• Preventable describes an event that could have been
anticipated and prepared for, but that occurs because of an
error or other system failure.
• Restraints is defined by The Joint Commission, the Centers
National Quality Forum
Appendix B - Glossary
for Medicare & Medicaid Services, and by some states.
The appropriate source(s) should be consulted for the
definition required by the setting and/or jurisdiction in
which a presumptive event occurs. In the event none of
those definitions apply to an institution, the following
definition, which is intended to capture definitions
from the named organizations, is offered: Restraints
means any method of restricting a patient’s freedom of
movement that is not a usual and customary part of a
medical diagnostic or treatment procedure to which the
patient or his or her legal representative has consented;
is not indicated to treat the patient’s medical condition or
symptoms; or does not promote the patient’s independent
functioning.
• Serious describes an event that can result in death, loss
of a body part, disability, loss of bodily function, or require
major intervention for correction (e.g., higher level of care,
surgery).
• Sexual abuse is defined as the forcing of unwanted sexual
activity by one person on another, as by the use of threats
or coercion or sexual activity that is deemed improper or
harmful, as between an adult and a minor or with a person
of diminished mental capacity.
• Surgery is an invasive operative procedure in which skin
or mucous membranes and connective tissue is incised
or the procedure is carried out using an instrument that
is introduced through a natural body orifice. It includes
minimally invasive procedures involving biopsies or
placement of probes or catheters requiring the entry
into a body cavity through a needle or trocar. Surgeries
include a range of procedures from minimally invasive
dermatological procedures (biopsy, excision, and deep
cryotherapy for malignant lesions) to vaginal birth or
Caesarian delivery to extensive multiorgan transplantation.
It does not include use of such things as otoscopes and
drawing blood. Organizations may choose to adopt a list
of surgical procedures to supplement the definition above;
one example of such a list in common use is that of the
Institute of Clinical Systems Improvement.
• Surgery ends after all incisions or procedural access routes
have been closed in their entirety, device(s) such as probes
or instruments have been removed, and, if relevant, final
surgical counts confirming accuracy of counts and resolving
any discrepancies have concluded and the patient has been
taken from the operating/procedure room.
• Unambiguous refers to an event that is clearly defined and
easily identified.
• Unintended retention of a foreign object refers to a foreign
object introduced into the body during a surgical or other
invasive procedure, without removal prior to the end of
the surgery or procedure, which the surgeon or other
practitioner did not intend to leave in the body.
NOTES
1. Food and Drug Administration. Available at http://www.
fda.gov/MedicalDevices/DeviceRegulationandGuidance/
Overview/ClassifyYourDevice/ucm051512.htm Last accessed January 19, 2011.
2. National Coordinating Council for Medication Error Reporting
and Prevention. Available at http://www.nccmerp.org/
aboutMedErrors.html. Last accessed January 7, 2011.
3. Minnesota Department of Health.
4. National Pressure Ulcer Advisory Panel. Available at:
http:www.npuap.org/Final_Quick_Treatment_for_
web_2010.pdf . Last accessed January 31, 2011.
5. National Pressure Ulcer Advisory Panel. Available
at: http:www.npuap.org/Final_Quick_Treatment_for_
web_2010.pdf . Last accessed January 31, 2011.
6. National Pressure Ulcer Advisory Panel. Available at:
http:www.npuap.org/Final_Quick_Treatment_for_
web_2010.pdf . Last accessed January 31, 2011.
• Surgery begins, regardless of setting, at point of surgical
incision, tissue puncture, or insertion of instrument into
tissues, cavities, or organs.
B-4
National Quality Forum
Serious Reportable Events In Healthcare—2011
Update: A Consensus Report
Appendix C
Steering Committee, Technical Advisory Panels,
and NQF Staff
Steering Committee
Gregg S. Meyer, MD, MSc (Co-chair)
Massachusetts General Hospital
Boston, MA
Sally Tyler, MPA (Co-chair)
American Federation of State, County
and Municipal Employees
Washington, DC
Leah Binder
The Leapfrog Group
Washington, DC
Patrick Brennan, MD
University of Pennsylvania Health System
Philadelphia, PA
Tejal Gandhi, MD, MPH
Brigham and Women’s Hospital
Boston, MA
Susan Gentilli, MBA, RHIA, CPHQ
HealthPartners
Minneapolis, MN
Christine A. Goeschel, RN, MPA
Johns Hopkins University School of Medicine
Baltimore, MD
Kevin P. High, MD, MS
Wake Forest University School of Medicine
Winston-Salem, NC
Cynthia N. Hoen, Esq, MPH, FACHE
Atlantic Health
Morristown, NJ
C-1
Helen Lau, RN, MHROD, BSN, BMus
Kaiser Permanente
Oakland, CA
Michael Victoroff, MD
Lynxcare
Centennial, CO
Kathryn J. McDonagh, PhD
Hospira
Lake Forest, IL
Ambulatory and Office-Based
Surgery Technical Advisory Panel
John Morley, MD, FACP
State of New York Department of Health
Office of Health Systems Management
Albany, NY
Stancel M. Riley, Jr., MD, MPA, MPH
(Chair)
Massachusetts Board of Registration in
Medicine
Wakefield, MA
Deborah Nadzam, PhD, RN, FAAN
Joint Commission Resources, Inc.
Westlake, OH
Martha J. Radford, MD, FACC, FAHA
New York University School of Medicine
New York, NY
Stancel M. Riley, Jr., MD, MPA, MPH
Massachusetts Board of Registration in
Medicine
Wakefield, MA
Diane Rydrych, MA
Minnesota Department of Health
St. Paul, MN
Doron Schneider, MD, FACP
Abington Memorial Hospital
Abington, PA
Philip J. Schneider, MS, FASHP
University of Arizona College of Pharmacy
Phoenix, AZ
Eric Tangalos, MD, FACP, AGSF, CMD
Mayo Clinic
Rochester, MN
James P. Bagian, MD
Veterans Health Administration
Department of Veterans Affairs
Ann Arbor, MI
Leigh Hamby, MD, MHA
Piedmont Healthcare
Atlanta, GA
William B. Rosenblatt, MD
Medical Society of the State of New York
New York, NY
Gina Throneberry, RN, MBA, CASC,
CNOR
Symbion Healthcare
Nashville, TN
Richard Urman, MD, MBA
Harvard Medical School
Boston, MA
Deborah Wheeler
United HealthCare
Las Vegas, NV
National Quality Forum
Serious Reportable Events In Healthcare—2011
Update: A Consensus Report
Appendix C
Steering Committee, Technical Advisory Panels,
and NQF Staff (cont.)
Physician Office Technical
Advisory Panel
Tejal Gandhi, MD, MPH (Chair)
Partners Healthcare
Boston, MA
Steven Kaplan, MD, FACEP
New York Presbyterian Hospital
New York, NY
Catherine C. Roberts, MD
Mayo Clinic
Phoenix, AZ
Michael A. Steinman, MD
University of California, San Francisco
San Francisco, CA
Diana Swanson, MSN, NP-C
American Academy of Nurse Practitioners
Bloomington, IN
James S. Taylor, MD
Cleveland Clinic
Cleveland, OH
C-2
Saul N. Weingart, MD, PhD
Dana-Farber Cancer Institute
Boston, MA
Gloria J. Jelinek, RN, MSN, JD
Kindred Healthcare
Louisville, KY
Elizabeth Wertz Evans, RN
PANDA and Associates, LLC
Pittsburgh, PA
James E. Lett, II, MD, CMD
American Medical Directors Association
Carmichael,CA
Skilled Nursing Facility Technical
Advisory Panel
Laura M. Wagner, PhD, RN
New York University College of Nursing
New York, NY
Eric Tangalos, MD, FACP, AGSF, CMD
(Chair)
Mayo Clinic
Rochester, MN
Debra P. Bakerjian, PhD, MSN, FNP
Betty Irene Moore School of Nursing
Sacramento, CA
Stefan Gravenstein, MD, MPH, CMD
Quality Partners at Rhode Island
Providence, RI
Randall D. Huss, MD
St. John’s Clinic
Rolla, MO
NQF Staff
Helen Burstin, MD, MPH
Senior Vice President
Performance Measures
Peter Angood, MD
Senior Advisor
Patient Safety
Melinda L. Murphy, RN, MS
Clinical Consultant
Lindsey Tighe, MS
Research Analyst
National Quality Forum
THE NATIONAL QUALITY FORUM (NQF) is a private, nonprofit, open membership,
public benefit corporation whose mission is to improve the American healthcare system
so that it can be counted on to provide safe, timely, compassionate, and accountable
care using the best current knowledge. Established in 1999, NQF is a unique publicprivate partnership having broad participation from all parts of the healthcare industry.
As a voluntary consensus standard-setting organization, NQF seeks to develop a common vision for healthcare quality improvement, create a foundation for standardized
healthcare performance data collection and reporting, and identify a national strategy
for healthcare quality improvement. NQF provides an equitable mechanism for addressing the disparate priorities of healthcare’s many stakeholders.
NATIONAL QUALITY FORUM
601 13th Street NW
Suite 500 North
Washington, DC 20005
202-783-1300
www.qualityforum.org